The Pro Check™ Digital Pacifier Thermometer, is a non-sterile, re-usable clinical thermometer intended for the determination of oral body temperature in infants to children five years of age.

Device Description

The Pro Check™ Digital Pacifier Thermometer, is a battery-powered, liquid crystal display device using a thermometer embedded in the nipple. The patient contact portion is composed of medical silicone rubber. The body is of ABS plastic. This device is reusable and no components are disposable. This device is not intended for use with other sheaths or devices.

AI/ML Overview

The Pro Check™ Digital Pacifier Thermometer relies on previously performed clinical testing for predicate devices (Pasi-Temp Pacifier Digital Thermometer and Basis® Temp Pacifier Digital Thermometer) to demonstrate substantial equivalence. Therefore, the information provided focuses on the predicate devices' performance.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (from predicate devices)
Conformance to ASTM® #1112 "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature" physical requirements and operating parameters.	The Pro Check™ Digital Pacifier Thermometer conforms to ASTM® #1112, based on the predicate devices.
Compliance with EPA requirements for nitrosamines.	The Pro Check™ Digital Pacifier Thermometer meets EPA requirements for nitrosamines, based on the predicate devices.
Compliance with CPSC 1511 requirements for Baby Pacifiers (choking hazards).	The Pro Check™ Digital Pacifier Thermometer meets CPSC 1511 requirements, based on the predicate devices.

Study Details (Inferred from Predicate Device Information)

Since the Pro Check™ Digital Pacifier Thermometer directly references clinical testing from its predicate devices, the specifics below apply to those predicate devices and are attributed to the Pro Check™ by reference.

Sample size used for the test set and the data provenance: Not explicitly stated in the provided document. The document only mentions "Clinical testing previously performed."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not explicitly stated.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a digital thermometer, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a standalone thermometer, meaning its performance is measured directly, not as an algorithm assisting human interpretation. The clinical testing likely evaluated its accuracy in measuring temperature.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, but for a thermometer, the ground truth would typically be a highly accurate reference thermometer (e.g., a calibrated laboratory thermometer) against which the device's temperature readings are compared.
The sample size for the training set: Not applicable, as this is a traditional medical device not employing machine learning that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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K972259

JUL | 0 |997 EXHIBIT #1

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 9807.92.

The assigned 510(k) number is: ________________

1. Submitter's Identification:

Micro Weiss Electronics 89 Bell Street W. Babylon, NY 11704 Contact: Mr. John Weiss

Date Summary Prepared: June 13, 1997

2. Name of the Device:

Pro Check™ Digital Pacifier Thermometer

3. Predicate Device Information:

The Pasi-Temp Pacifier Digital Thermometer, K#952073, Intelligent Product Ltd. Co., Orem, Utah (presently owned by Acute Ideas Co., Ltd.)
The Basis® Baby-Temp Pacifier Digital Thermometer, K#962991, Polymedica Industries, Inc., Golden, Colorado.

4. Device Description:

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5. Intended Use:

The Pro Check™ Digital Pacifier Thermometer, is a non-ster'le, re-usable clinical thermometer intended for the determination of oral body temperature in infants to children five vears of age.

6. Comparison to Predicate Devices:

The Pro Check™ Digital Pacifier Thermometer, is identical to the Pasi-Temp Pacifier Digital Thermometer and the Basis® Baby-Temp Pacifier Digital Thermometer.

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

The Pro Check™ Digital Pacifier Thermometer, conforms to physical requirements and operating parameters outlined in ASTN® #1112, "Standard Specification for Electronic Thermometer for Intermitter t Determination of Patient Temperature". It also meets EPA requirements for nitrosamines and Consumer Product Safety Commission (CPSC 1511) recuirements by Baby Pacifiers (choking hazards).

8. Discussion of Clinical Tests Performed:

Clinical testing previously performed for the Pasi-Temp and Basis® Temp Pacifier Digital Thermometer also apply to the Pro Check™ Digital Pacifier Thermometer.

9. Conclusions:

The Pro Check™ Digital Pacifier Thermometer, is identical in intended use, design, material and technology as the Pasi-Temp and Basis® Temp Pacifier Digital Thermometers. Thus, when compared to the predicate devices, the Pro Check™ Digital Pacifier Thermometer, does not incorporate any changes in intended use, method of operation, material or design that could affect safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Susan Goldstein-Falk Official Correspondent Micro Weiss Electronics C/O MDI Consultants, Incorporated 55 Northern Boulevard, Suite 410 Great Neck, New York 11021

.IUL | 0 |997

K972259 Re : Pro Check Digital Pacifier Thermometer Trade Name: Requlatory Class: II Product Code: FLL Dated: June 13, 1997 Received: June 17, 1997

Dear Ms. Goldstein-Falk:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Goldstein-Falk

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The ₽ÐA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene regaración chorosos, "htbbanding ay "Dreadly" (2010).
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Time Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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EXHIBIT B Page 1 of 1 --

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Check™ Digital Pacifier Thermometer Pro Device Name:_

Indications For Use:

Pre (Pe

The Pro Check™ Digital Pacifier Thermometer, is a non-sterile, re-usable clinical thermometer intended for the determination of oral body temperature in infants to children five years of age.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)	Patricia Crucetti
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K972259
Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use ✓

(Optional Format 1-2-96)

ー.

Regulation Number and Section

§ 880.2910 Clinical electronic thermometer.

(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.